A Study of ZL-1310 in Participants With Selected Solid Tumors
Launched by ZAI LAB (SHANGHAI) CO., LTD. · Mar 19, 2025
Trial Information
Current as of April 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This is an open-label, multiple-center, phase Ib/II study of ZL-1310 in selected solid tumors.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Signed informed consent
- • Adult men and women ≥18 years of age
- • Participants must have histologically confirmed, locally advanced or metastatic NECs, and must have experienced disease progression on or after platinum-based therapy
- • Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
- • Participants must have at least one measurable target lesion as defined by RECIST v1.1
- • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- • Life expectancy ≥ 3 months
- Exclusion Criteria:
- • Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
- • Clinically active central nervous system (CNS) metastases
- • Participants with leptomeningeal metastasis
- • Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)
- • Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment
- • Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or a history of radiation pneumonitis
- • Major surgery within 4 weeks of the first dose of study treatment
- • Hypersensitivity to any ingredient of the study treatment
- • Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment
- • Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
- • Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis
- • Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
- • Pregnant or nursing (lactating) women
- • Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer
About Zai Lab (Shanghai) Co., Ltd.
Zai Lab (Shanghai) Co., Ltd. is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapies to address significant unmet medical needs in oncology, autoimmune diseases, and infectious diseases. Founded in 2014, Zai Lab leverages advanced technologies and a robust pipeline of proprietary and partnered programs to bring cutting-edge treatments to patients in China and globally. With a strong focus on research and development, the company is committed to transforming the landscape of healthcare through scientific excellence and strategic collaborations, positioning itself as a key player in the global biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported